ADMA Biologics, Inc – FDA EIR, Aug 12, 2021

An FDA surveillance inspection of ADMA Biologics Inc. in Boca Raton, FL, was conducted from August 3 to August 12, 2021. The inspection, performed under C.P. 7345.848 and as part of the Team Biologics FY’ 2021 Workplan, evaluated the manufacturing of licensed biological bulk drug substances like BIVIGAM®, ASCENIV®, and NABI-HB®. The review focused on the Quality, Production, Laboratory, and Facilities & Equipment systems, adhering to cGMP, 21 CFR Part 640, ICH, and USP guidelines.The inspection revealed several Current Good Manufacturing Practice (cGMP) deficiencies. Key issues included a lack of adequate Quality Assurance oversight, leading to contamination of viable air samplers and the spread of organisms within manufacturing areas. Furthermore, in-process specifications for protein absorbance were found to be inconsistent with final drug product specifications, lacking scientific rationale for certain relative standard deviation (RSD) criteria. The facility's buildings, used for manufacturing and storage of plasma-derived bulk drug substances, were not consistently maintained, with observations of floor damage and ceiling stains in critical areas like plasma and reserve sample storage. Additionally, the change control procedure did not adequately define criteria for minor changes requiring annual reporting to the FDA.At the conclusion of the inspection, a Form FDA-483, Inspectional Observations, was issued to ADMA Biologics Inc., detailing these deficiencies. This requires the company to address the noted observations with corrective actions to ensure compliance with regulatory standards.